FDA Authorizes Marketing of New Dexcom G6® CGM

SAN DIEGO – March 27, 2018 – DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. The powerful and revolutionary new Dexcom G6® is the first CGM to receive this classification by the FDA.

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Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring CGM accuracy, reliability and clinical relevance as well as describe the type of studies and data required to demonstrate acceptable CGM performance.

“As a factory-calibrated, real-time CGM system with exceptional accuracy, the Dexcom G6® will be transformative for people with diabetes, who will no longer be required to prick their fingers for diabetes management,” said Daniel DeSalvo, MD, Pediatric Endocrinologist at Texas Children’s Hospital in Houston, Texas. “I can tell you as someone who has Type 1 Diabetes myself, with all of its features and benefits, the Dexcom G6® is the CGM device I have been anticipating for the last twenty years. This CGM system will help to alleviate the burden of diabetes management while improving the lives of people with diabetes.”

“Contemporary diabetes technology relies on accuracy and performance, which Dexcom has proven over time. Once again, Dexcom has earned the trust of the research community all over the world,” said Boris Kovatchev, PhD and founding director of the UVA Center for Diabetes Technology. “Innovations like the Dexcom G6® are critical to closing the loop – automated insulin delivery known as the ‘artificial pancreas’.”

“We listen closely to people with diabetes and continuously look for ways to empower them to better manage their condition. The FDA’s special controls set a rigorous, new standard in our industry and clearly define the process by which other CGM systems may be approved.,” said Kevin Sayer, Chief Executive Officer of Dexcom. “We believe the new Dexcom G6® is a significant step forward for Dexcom and our industry.”

The company expects to launch later this year. For more information, visit www.dexcom.com/G6.

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Conference Call
The company will host a conference call at 8:00 A.M. Eastern Time on Wednesday, March 28, 2018. To listen to the conference call, please dial (888) 771-4371 (US/Canada) or (847) 585-4405(International) and use the confirmation number “46726870” approximately five minutes prior to the start time.

About CGM
CGM devices are considered the most significant breakthrough in diabetes management in the past 40 years1 and Dexcom has been a leader of those innovations. Diabetes affects nearly 30 million Americans and is the seventh leading cause of death in the United States2. The traditional standard-of-care for glucose monitoring has been a fingerstick meter, which is painful as some patients needed to test their blood up to 12 times a day. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose levels are too low or too high. People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death3,4. To learn more about CGM, visit www.dexcom.com.

About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked DexCom highest in customer satisfaction and loyalty. For more information on the Dexcom CGM, visit www.dexcom.com.

| December 8th 2014

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